LEO Pharma

IT Compliance Manager

Ensuring quality and compliance as a trusted advisor for our global organisation

Do you have solid experience from working across quality and IT and are you looking for a job with massive impact and influence, this may be the role you are looking for.
LEO Pharma is on a digital transformation journey which requires new and innovative ways to ensure the required level of security and compliance for a regulated business as LEO Pharma. To be successful in this journey we will adopt Lean-Agile ways of working across LEO Pharma.

Set direction and advice colleagues at all levels

Your overall objective is to ensure that we are in compliance with rules and regulations across our global IT systems – GXP as well as non-GxP systems. Your foundation will be our IT Quality Management System (IT QMS), for which you will contribute to the on-going optimisation and adaptation to support the enablement of new technologies.

Your role is first and foremost as an advisor in order to ensure the right level of quality is delivered. Your primary responsibility will be to:

  • Set the direction for compliance in IT projects and services to ensure inspection readiness
  • Drive the continuous improvement of LEO Pharma’s IT QMS through updating existing SOPs and ensuring that the organization is trained and ready to operate
  • Review and approve non-GXP project documentation and review and approval of non-GXP suppliers
  • Lead and guide external suppliers and partners to ensure a well-balanced level of performance

Experience across IT, quality and advisory

You have a relevant bachelor’s degree or master’s degree. You have at least five years’ experience comprising quality and IT – not necessarily at the same time. Ideally, you have knowledge of the pharma industry and the related GxP regulations, but it is not a prerequisite for applying.

You are comfortable in the role as trusted advisor, and you have the overview, confidence and communications skills it takes to provide clear-cut advice – to people at all levels and across cultural, geographical and professional borders. You work with a pragmatic attitude, and you have the ability to prioritise among multiple tasks and find the right level of quality needed. Related to this, you are a true executor – you can make decisions, follow through, close cases and move on to the next in line.

Your new team

You will join a team of six dedicated and experienced compliance managers and compliance service delivery managers. As accountable for regulatory compliance in Global IT we plan and maintain LEO Pharma’s IT QMS. We continuously strive to make it easy for the Global IT organisation to do the right things right. We manage the execution and follow up on internal and regulatory inspections within Global IT. Our environment is characterised by an open dialogue, helpfulness and a common will to move things forward.

Contact and application

Please apply at our website. The deadline is 14th of April 2020. If you have any questions, you are very welcome to contact Claus Brandorff, Head of Compliance Services at +45 5385 2431
We look forward to receiving your application.

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Application deadline:

14/04/2020

Location:

Ballerup, Greater Copenhagen

Contacts:

Claus Brandorff

Mobile: +45 5385 2431

Company homepage:

http://www.leopharma.com

Office address: